IntelliStent for Pulmonary Flow Adjustment in Congenital Heart Disease and Dilated Cardiomyopathy (HEARTFUL-CHD)

Clinical Evaluation of HeartPoint Global Intellistent for Pulmonary Flow Adjustment in Congenital Heart Disease and Dilated Cardiomyopathy

IntelliStent is intended to achieve reduction of pulmonary hypertension, improvements in symptoms and quality of life in pediatric, adolescent and adult patients with congenital heart disease associated pulmonary arterial hypertension or left ventricular dilated cardiomyopathy.

Study Overview

• Status: Not yet recruiting
• Conditions: Pulmonary Arterial Hypertension; Dilated Cardiomyopathy; Congenital Heart Disease
• Intervention / Treatment: Device: IntelliStent

Detailed Description

IntelliStent Implant System is a kit of stents for adjustable interventional reduction of blood flow through a novel and minimally invasive intervention to replace surgical Pulmonary Artery Banding (PAB).

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Monica Tocchi, MD, PhD; Phone Number: +1 646 933 1025; Email: m.tocchi@meditrial.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age: Adolescent (12-17 years) or Adult (age >18 years)
2. Uncorrected CHD (ASD, VSD, PDA, AVSD) with left to right + systemic pulmonary artery pressure or mixed shunting regardless if pulmonary vascular resistance is modifiable or fixed

3. Diagnosed with WHO Group 1 PH Classification pulmonary hypertension associated with congenital heart disease, evidence by the following parameters measured at rest:

   1. Mean pulmonary artery pressure (mPAP) ≥ 50 mmHg

   2. Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP)

      ≤ 15 mmHg.

   3. Pulmonary vascular resistance > 3 Wood Units
4. Patients with left ventricular dilated cardiomyopathy with symptoms despite optimal medical therapy
5. Current WHO Functional Class III or IV.

6. Patients with the following anatomical dimensions (gated CT with angio or MRI with EKG) at target implantation site:

   1. MPA diameter @ systolic ≥ 15 mm and ≤ 24 mm and length @ systolic ≥ 28 mm, or
   2. Left and Right PA Branch diameter @ systolic ≥ 15 mm and ≤ 24 mm and length @ systolic ≥ 28 mm
7. Main pulmonary artery (MPA) or left/right PA Branch anatomy suitable for placement of the device as defined in the Instructions For Use (IFU) and as assessed by computed tomography (CT), fluoroscopy or echocardiography.
8. Each patient, or his or her guardian or legal representative, is willing to give informed consent, subject to national law.

Exclusion Criteria:

1. Right ventricular dysfunction
2. Severe AV valve regurgitation of the pulmonary ventricle
3. Complex CHD
4. Ongoing infection
5. Patients where definitive correction of the CHD is indicated and available as a possible treatment option
6. Patients with pressure gradient across the systemic outflow tract/subaortic region >40 mmHg @ rest
7. PAH-CHD patients with small defects that may be incidental findings
8. PAH after corrective cardiac surgery
9. Anatomical limitation to IntelliStent® (e.g. pulmonary artery size)
10. Known or suspected thrombosis of the femoral or iliac veins on the proposed site of venous cannulation
11. Vasculature lesions or characteristics that prevent percutaneous transluminal catheterization
12. Allergies or contraindications to prescribed procedural medications and contrast medium Anomalous pulmonary venous return (total or partial)
13. Likely inability to comply with the protocol or cooperate fully with the investigator and site personnel
14. Mental incapacity, unwillingness or language barrier precluding adequate understanding of the trial procedure or cooperation with trial site personnel
15. Pregnant, lactating or planning pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: IntelliStent Arm; Single Arm Safety and Effectiveness of the IntelliStent System

Device: IntelliStent; Staged implantation of IntelliStent. The system comprises a nitinol self-expanding stent with a hollow element delivered over-the-wire into the main pulmonary artery or its left and right branches, using an 18 Fr transfemoral introducer sheath. The stent consists of two sections, one with a larger diameter and one with a smaller diameter, available in 6 sizes suitable for vessel sizes ranging from 20mm to 30 mm. Additional smaller sizes are currently under development.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pulmonary vascular resistance (PVR)	The primary efficacy endpoint is a binary variable. For patients with a baseline pulmonary vascular resistance (PVR) >1000 dynes·s·cm-5, success is defined by an absolute reduction in PVR of ≥300 dynes·s·cm-5 at 24 weeks. For patients with a baseline PVR ≤1000 dynes·s·cm-5, success is a 30% reduction in PVR at 24 weeks.	24 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Six Minute Walk Test Distance	Change from baseline of six minute walk test distance (meters) at Week 12.	12 Weeks
Change From Baseline to Week 12 in Borg Dyspnea Score	The Borg Dyspnea score is a self-rating scale to evaluate the severity of dyspnea (from 0 "no shortness of breath at all" to 10 "very, very severe / maximal" shortness of breath).	Baseline to 12 weeks
NYHA Class change from Baseline at Week 12	New York Heart Association Class (NYHA) class: minimum I; maximum IV ( worse)	Baseline to 12 weeks
Change From Baseline to Week 12 in Ejection Fraction	Ejection Fraction (%) measured by transthoracic echocardiography	Baseline to 12 Weeks
Change From Baseline to Week 12 in Left Ventricular Volumes	Left Ventricular Volumes measured by transthoracic echocardiography	Baseline to 12 Weeks
Change From Baseline of the Kansas City Cardiomyopathy Questionnaire (KCCQ)	KCCQ scores for quality of life are scaled from 0 to 100 and summarized in 25-point ranges: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent	Baseline to 12 Weeks

Collaborators and Investigators

• Sponsor: HeartPoint Global
• Collaborators: Meditrial USA Inc.
• Investigators: Study Director: Monica Tocchi, MD, PhD, Meditrial USA Inc. Clinical Research Organization

Publications and helpful links

Helpful Links

• Meditrial Clinical Research Organization
• Heartpoint Global

Study record dates

Study Major Dates

• Study Start (Estimated): June 4, 2024
• Primary Completion (Estimated): June 4, 2025
• Study Completion (Estimated): June 4, 2026

Study Registration Dates

• First Submitted: October 3, 2023
• First Submitted That Met QC Criteria: October 6, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: dilated cardiomyopathy; pulmonary arterial hypertension; pediatric cardiology
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Congenital Abnormalities; Genetic Diseases, Inborn; Hypertension, Pulmonary; Cardiovascular Abnormalities; Cardiomegaly; Laminopathies; Heart Diseases; Hypertension; Pulmonary Arterial Hypertension; Cardiomyopathies; Cardiomyopathy, Dilated; Heart Defects, Congenital
• Other Study ID Numbers: HPG-001-23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The dataset generated during and/or analysed during the study will be available upon request from the Clinical Research Organization, Meditrial USA Inc. m.tocchi@meditrial.net Datasets will only be made available through publication, unless disclosure is mandated by law
• IPD Sharing Time Frame: Intention to publish date 09/01/2024
• IPD Sharing Access Criteria: Available on request, Published as a supplement to the results publication.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No